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Breast cancer IHC/ISH portfolio

Breast IHC Assays
Deliver diagnostic confidence with the Roche breast cancer IHC/ISH portfolio

A leader in breast cancer diagnostics, Roche Diagnostics offers numerous cancer diagnostic assays that enable pathology labs to deliver accurate results with confidence. We provide a robust menu of breast cancer diagnostic tools. Our portfolio of products delivers the high sensitivity and specificity you need from your assays.

Immunohistochemistry (IHC) analysis and in situ hybridisation (ISH) analysis

In England, breast cancer represented 15.1% of the total number of cancers diagnosed in 20171. In developed countries breast cancer-related mortality has declined, in part due to therapeutic advances and evolution of biomarkers. For example, Immunohistochemistry (IHC) analysis and in situ hybridisation (ISH) analysis provide important information related to tumour biology, help profile types of breast cancer and may improve treatment decisions.

Clinical benefit

The VENTANA breast cancer diagnostic assays could be used to aid in diagnosing patients with breast cancer at various stages. This could assist the clinician with either early detection or personalised treatment options.

Analytical advantage

Specific and sensitive rabbit monoclonal antibodies, best-in-class probes and powerful detection systems help you diagnose precisely and confidently.

Testing efficiency

Our comprehensive breast cancer workflow solution delivers fully-automated assays, with digital pathology and workflow solutions that free resources, reduce labour costs and time to results.

Featured Assays

SP1
CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody
  • CE IVD approved antibody
  • Indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.2
  • ER (SP1) is a significant predictor of disease-specific survival.3,4
  • Rapid and consistent results delivered through fully automated platforms and digital pathology solutions
HER2
VENTANA HER2 Dual ISH DNA Probe Cocktail assay
  • CE IVD approved test
  • Increased performance with oligo probes and new detection kits
  • Easily interpreted using brightfield microscopy
  • Robust and highly reproducible between laboratories and pathologists
  • Highly concordant with FISH
HER2
INFORM HER2 Dual ISH DNA Probe Cocktail assay
  • CE IVD antibody-approved test
  • Convenient brightfield detection technology to perform a comprehensive analysis of tissue on the slide, and evaluate HER2 gene status with morphological context
  • Identify intratumoral heterogeneity
  • Greatly reduced time to results with full automation5,6
  • Run the test in-house instead of sending it out
HER2 4B5
PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody
  • CE IVD approved antibody
  • Higher overall proficiency assessment scores with HER2 (4B5) than with any other clones7
  • Widely adopted and reliable HER2 IHC primary antibody3
  • High concordance with HER2 ISH8,9
PR
CONFIRM PR (1E2) Rabbit Monoclonal Primary Antibody
  • CE IVD approved antibody
  • Indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.10
  • Provide significant value as a prognostic factor and response prediction of hormone therapy, even in ER negative patients.11
  • Rapid and consistent results through fully automated platforms and digital pathology solutions
KI-67
CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody
  • Aids in assessing the proliferative activity of normal and neoplastic cells
  • Rabbit monoclonal antibody demonstrates increased sensitivity and strong specificity compared with mouse monoclonal antibodies
  • Intense nuclear staining and no adipose (K2) or cell membrane staining can help deliver a confident assessment of tumor aggressiveness

References

  1. Office for National Statistics. Cancer registration statistics, England: 2017 [Date June 2020]:  https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/2017.
  2. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
  3. Welsh A, et al. Quantitative Analysis of Estrogen Receptor Expression Shows SP1 Antibody Is More Sensitive Than 1D5. Appl Immunohistochem Mol Morphol. 2013;21(2):139-147.
  4. Yamamoto-Ibusuki M, Yamamoto Y, Yamamoto S, et al. Comparison of prognostic values between combined immunohistochemical score of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, Ki-67 and the corresponding gene expression score in breast cancer. Mod Patholo 2013: 26):79–86.
  5. Loftin IR, et al. The new FDA-approved INFORM HER2 Dual ISH assay is concordant to FISH and reproducible in determining HER2 gene status in invasive breast carcinoma. Poster presented at the ASCO Breast Cancer Symposium; 2011; September 8-10: San Francisco, California, USA.
  6. Paolini D, Rossoni R, Guardione D, Vrena V. Economical and organizational impact of adopting different in situ hybridization technologies to assess HER2 gene amplification in breast cancer. Poster presented at the 18th Annual European.
  7. Based on 5 years of data from a leading external quality assessment scheme. Retrieved from http://www.nordiqc.org/epitopes.htm.
  8. Mayr D, et al. Comprehensive immunohistochemical analysis of Her-2/ neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (VENTANA) for VENTANA BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Archiv. 2009; 454(3): 241–248.
  9. Brügmann A, Lelkaitis G, Nielsen S, et al. Testing HER2 in breast cancer: a comparative study on BRISH, FISH, and IHC. Appl Immunohistochem Mol Morphol. 2011;19(3):203-211.
  10. 8 CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
  11. Liu, S, Chia SK, Mehl, E, et al. Breast Cancer Res Treat. Progesterone receptor is a significant factor associated with clinical outcomes and effect of adjuvant tamoxifen therapy in breast cancer patients. 2010;119:53-61.